| CTRI Number |
CTRI/2023/07/055116 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Kushadya kshar on Gall bladder stones |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Kushadya kshar in the management of Pittashaya ashmari W.S.R. to Cholelithiasis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunita Yadav |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malaviya Government Ayurved college Udaipur |
| Address |
PG Scholar
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9672534733 |
| Fax |
|
| Email |
sy268593@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malaviya Government Ayurved College Udaipur |
| Address |
Associate Professor
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malaviya Government Ayurved College Udaipur |
| Address |
Associate Professor
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malaviya Government Ayurved college Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malaviya Government Ayurved college Udaipur |
| Address |
Madan Mohan Malaviya Government Ayurved college Udaipur
PIN 313001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunita |
Madan Mohan Malaviya Government Ayurved College Udaipur |
OPD No 1
PG Department of Shalya tantra
Associated group of hospitals
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur
RAJASTHAN |
9672534733
sy268593@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,M.M.M. Govt.Ayurved College,Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K808||Other cholelithiasis. Ayurveda Condition: PITTAJA-ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushadya kshar, Reference: Chakradutta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients suffering from signs and symptoms of pittashaya ashmari
2)Solitary and multiple gall stones of size 1-8mm. |
|
| ExclusionCriteria |
| Details |
1)Age below 20 yrs and above 60 yrs
2)Gall stones present in cystic duct and CBD
3)Congenital anomalies of hepatobilliary system |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs & symptoms of pittashaya ashmari
2)Reduction in the size of gall stones
3)Reduction in pain,vomiting,nausea & dyspepsia |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs & symptoms of pittashaya ashmari
2)Reduction in the size of gall stones
3)Reduction in pain,vomiting,nausea & dyspepsia |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single arm study to evaluate the efficacy of Kushadya kshar in the management of pittashaya ashmari.In this study Kushadya kshar will be administered to selected 30 patients,at the dosage of 250 mg,bd,after food for the duration of 1 month. |